Safety and Efficacy of a Once-Daily Halobetasol Propionate 0.01% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: Results of Two Phase 3 Randomized Controlled Trials
October 2018 | Volume 17 | Issue 10 | Original Article | 1062 | Copyright © October 2018
Lawrence J. Green MD,a Francisco A. Kerdel MD,b Fran E. Cook-Bolden MD,c Jerry Bagel MD,d Tina Lin PharmD,e Gina Martin MOT,f Radhakrishnan Pillai PhD,f Robert Israel MD,g Tage Ramakrishna MDg
aGeorge Washington University School of Medicine, Washington, DC bFlorida Academic Dermatology Centers, Miami, FL cSkin Specialty Dermatology and Department of Dermatology, Mount Sinai Hospital Center, New York, NY dPsoriasis Treatment Center of Central New Jersey, East Windsor, NJ eOrtho Dermatologics, Bridgewater, NJ fDow Pharmaceutical Sciences Inc., Petaluma, CA gBausch Health, Bridgewater, NJ
OBJECTIVE: Investigate safety and efficacy of halobetasol propionate 0.01% lotion in moderate-to-severe plaque psoriasis.
METHODS: Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Subjects randomized (2:1) to halobetasol propionate 0.01% lotion or vehicle once-daily for 8 weeks, 4-week posttreatment follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in Investigator Global Assessment [IGA] score and ‘clear’ or ‘almost clear’) at week 8. Safety and treatment emergent adverse events (AEs) evaluated throughout. RESULTS: Halobetasol propionate 0.01% lotion demonstrated statistically significant superiority over vehicle as early as week 2. By week 8, 36.5% (Study 1) and 38.4% (Study 2) of subjects were treatment successes compared with 8.1% and 12.0% on vehicle (P less than 0.001). Halobetasol propionate 0.01% lotion was also superior in reducing psoriasis signs and symptoms, body surface area (BSA), and improving quality of life. Halobetasol propionate 0.01% lotion was well-tolerated with no treatment-related AEs greater than 1%.
LIMITATIONS: Study did not include subjects with BSA greater than 12.
CONCLUSIONS: Halobetasol propionate 0.01% lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, without the safety concerns of a longer treatment course.
J Drugs Dermatol. 2018;17(10):1062-1069.
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